Cannabidiol-assisted learning to help manage generalized anxiety
Official title: Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder
Run by Wayne State University · NCT07123467 · Data updated 2026-11-12
This trial will test whether adding FDA-approved cannabidiol (Epidiolex) to brief cognitive behavioral therapy helps adults 18–45 with generalized anxiety disorder improve emotion regulation and reduce anxiety symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07123467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–45 who are right-handed, medically and neurologically stable, can consent and follow study procedures, and have a current DSM-5 diagnosis of generalized anxiety disorder or a GAD-7 score of 8 or higher would be appropriate candidates.
✕Probably not a fit
People outside the 18–45 age range, those with significant medical or neurological conditions, current medications that interact with cannabidiol, active risk of harm, contraindications to MRI, or major cognitive impairment are unlikely to be eligible or to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 3 trial testing two doses of FDA-approved cannabidiol (Epidiolex) as an adjunct to brief cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder. Participants are randomly assigned to one of four arms (moderate-dose CBD, low-dose CBD, or matched placebos for each dose) and receive pre- and post-treatment functional MRI while performing an emotion-regulation task. The primary outcome is change in dorsomedial prefrontal cortex (dmPFC) activation as a neurobiological target, with secondary outcomes including anxiety symptom severity, tolerability, and plasma CBD-related biomarkers. The trial uses a neurobiologically informed experimental medicine approach to link target engagement with clinical outcomes.
Why it matters
Potential benefit: If successful, combining CBD with CBT could strengthen or speed emotion-regulation changes and lead to larger reductions in anxiety symptoms than CBT with placebo.
How similar studies have gone: Small human and animal studies have suggested acute anxiolytic effects of CBD, but using FDA-approved Epidiolex as an adjunct to CBT with fMRI-based target engagement is a novel approach without established proof of benefit.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Right-handed * Age 18-45 years at enrollment * Able to consent to the study * Agree to adhere to lifestyle considerations throughout study duration * Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment * Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and/or total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7) Exclusion Criteria: * Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol * Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol * Risk of harm to self or others that requires immediate intervention * Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX® * Positive drug screen or alcohol breathalyzer * Unwilling/unable to sign informed consent document * Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women), * Under 18 or over 45 years of age * Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement \[i.e., whiplash\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient) * Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner * Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles) * Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year * Current moderate or severe alcohol/drug use disorder or in the past 8 weeks * Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders; * GAD-7 score \< 8 * Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19) * Visual impairment * Baseline labs 3 times outside of normal range * Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \< 4 weeks), or intention to start new treatment during this trial * Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen) * Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness * Treatment with another investigational drug or intervention within the past month * Difficulty with or inability to comply with the complete clinical trial.
Where it's running
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Wayne State University School of Medicine, Tolan Park Medical Building
Detroit, Michigan, United States Recruiting
Study contacts
- Principal investigator: Hilary Marusak, PhD — Wayne State University
- Study coordinator: Hilary Marusak, PhD
- Email: hmarusak@med.wayne.edu
- Phone: (313) 577-1278
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.